Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Conditions

• Ulcerative Colitis (UC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• XmAb942 — BIOLOGICAL
  Antibody
• Placebo — DRUG
  Placebo

Study Details

Brief summary The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).

Key Dates

Start date

Oct 10, 2024

Status verified

Jun 2026

Primary completion

Apr 30, 2028

Completion

Jan 31, 2029

Study Design

Enrollment

270 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Part A: Active drug
  Active XmAb942 to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels of XmAb942 via SC (3 cohorts) or IV (3 cohorts) administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.
• Placebo Comparator: Part A: Placebo
  Placebo Comparator to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels will be randomized in a 3:1 ratio to active or placebo.
• Active Comparator: Part B: Active
  Active XmAb942 to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels of XmAb942 via IV administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.
• Placebo Comparator: Part B: Placebo
  Placebo Comparator to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels will be randomized in a 3:1 ratio to active or placebo.
• Active Comparator: Part C: Active
  Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis
• Placebo Comparator: Part C: placebo
  Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis

Primary Outcome Measure

Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A) [ Time Frame: 20 weeks ]

Central Contacts

• Sudeepta Aggarwal
  [email protected]
• Mark Osterman, MD, MSCE
  [email protected]

Locations (24)

Find similar trials in Scottsdale, AZ

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